Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy. [ Time Frame: 1 year ]

Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.

Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week

Drug: bevacizumab

Given intravenously every 2 weeks

Other Name: Avastin

Drug: vinorelbine

Given intravenously once a week

Other Name: Navelbine

Drug: trastuzumab

Given intravenously once a week

Other Name: Herceptin

Experimental: Second line treatment

Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.

Drug: bevacizumab

Given intravenously every 2 weeks

Other Name: Avastin

Drug: vinorelbine

Given intravenously once a week

Other Name: Navelbine

Drug: trastuzumab

Given intravenously once a week

Other Name: Herceptin

Detailed Description:

Participants will receive bevacizumab intravenously every 2 weeks. They will also receive trastuzumab and vinorelbine intravenously once a week. Therefore, treatments will alternate between receiving all three drugs (1st week, third week, fifth week, etc.) and receiving only trastuzumab and vinorelbine (2nd week, fourth week, sixth week, etc.) A treatment cycle lasts four weeks.

During all treatment cycles a physical exam will be performed and the participant will be asked general health and specific questions about any problems they are experiencing.

X-ray, CT scans, and/or MRI scans will be performed every 8 weeks (every 2 cycles) in order to assess the effect of the study treatment on the participants cancer. These tests are considered standard of care in patients receiving chemotherapy.

Once a week blood counts will be performed and at least every 4 weeks, chemistry and other tests to measure any additional effect of the study drug and disease status will be checked. These tests are also considered standard of care for patients receiving chemotherapy.

At the beginning of the study and at the 4- and 8-week time point, additional blood will be drawn in order to conduct research blood tests to measure the presence of cancer cells in the blood.

A urine test and MUGA scan or echocardiogram will be done every 8 weeks while the participant in on the study.

Participants can remain on the research study as long as the study treatment appears to be working and they are not experiencing unacceptable side effects.

Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater with conventional techniques or as 10mm or greater with spiral CT scan

18 years of age or older

Life expectancy of more than 12 weeks

ECOG Performance Status of 0 or 1

Normal organ and marrow function as outlined in the protocol

Left ventricular ejection fraction 50% or greater as determined by RVG or echocardiogram within 30 days prior to initiation of protocol therapy

Patients with stable or previously treated CNS metastases are eligible for study participation, provided there is no history of clinically significant CNS bleeding

Men and women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation

COHORT A:

No prior chemotherapy for treatment of metastatic breast cancer

May NOT have received prior treatment with trastuzumab for recurrent or metastatic breast cancer

No prior vinorelbine for treatment of breast cancer

No prior bevacizumab for treatment of breast cancer

May have received prior radiation therapy and/or any number of lines of hormonal therapy

Prior trastuzumab therapy in the adjuvant setting is also allowed, providing that relapse occured at least 12 months following the last dose

Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment

COHORT B:

One prior line of chemotherapy for treatment of metastatic breast cancer or recurrence of breast cancer within 12 months of completion of adjuvant trastuzumab

No prior vinorelbine for treatment of breast cancer

No prior bevacizumab for treatment of breast cancer

May have received prior radiation therapy and/or any number of lines of hormonal therapy

Must have recovered from all reversible toxicities related to prior therapy and may not have any pre-existing treatment-related toxicities in excess of Grade 1. Patients must have stopped prior radiation therapy at least 7 days prior to beginning protocol treatment

Exclusion Criteria:

Patients who have had chemotherapy within 14 days prior to entering the study, ot those who have not recovered adequately from adverse events due to agents administered earlier

Concurrent radiation therapy

History of Grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition as the agents used in this study

Prior therapy with bevacizumab or vinorelbine

Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study

Inadequately controlled hypertension

Prior history of hypertensive crisis of hypertensive encephalopathy

NHYA Grade II or greater congestive heart failure

History of myocardial infarction of unstable angina within 6 months prior to study enrollment

History of stroke or transient ischemic attack within 6 months prior to study enrollment

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study

Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior to study enrollment

History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment

Serious non-healing wound, active ulcer, or untreated bone fracture

Proteinuria at screening

Pregnant or lactating

Current and ongoing treatment with full-dose warfarin or its equivalent

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670982